Induced AbortionNCT01776957
Post Abortion IUD & Recurrent Abortion 2005-2006
An observational study of Induced Abortion, run by University of British Columbia.
Trial summary
The rate of repeat abortions will be lowest in those women who choose immediate insertion of an IUD post-abortion versus those who immediately choose oral contraceptive pills and those who indicate all other contraceptive choices including no contraception The provision by the health system of IUDs for immediate… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Induced Abortion
- What is being tested?
- Device: Intrauterine device (IUD)
- Type of treatment
- Medical device
- How many people
- 1,308 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Female resident of Interior Health region seeking an abortion
Who may be able to join
- Female resident of Interior Health region seeking an abortion between January 1, 2005 and December 31, 2006
Who cannot join
- Women undergoing abortions for fetal genetic abnormalities
About this study
Official title: Preventing Repeat Abortion: Is the Immediate Insertion of Intrauterine Devices Post-abortion a Cost-effective Option Associated With Fewer Repeat Abortions? Findings From 2005-2006 Data
The rate of repeat abortions will be lowest in those women who choose immediate insertion of an IUD post-abortion versus those who immediately choose oral contraceptive pills and those who indicate all other contraceptive choices including no contraception The provision by the health system of IUDs for immediate insertion will result in the lowest health system costs.
Read the detailed description
The investigators intend to demonstrate whether there are statistically significant differences in the rates of repeat abortions between three groups: 1. women choosing to have an intrauterine device (IUD) inserted immediately post-abortion, 2. those choosing to begin oral contraceptives immediately post-abortion, and 3. all other choices for post abortion contraception including those stating an intention to obtain contraceptives at a later time or from an alternate location or to use no contraception. This data will then be used to conduct a cost-effectiveness analysis of health system provision for cost-free IUDs post-abortion. Thus, if providing a free IUD immediately post-abortion significantly reduces the rate of repeat abortions, it may be more cost- effective for health system services to provide free IUDs at abortion clinics than to field the costs associated with a higher rate of repeat abortions.
The researchers will conduct a retrospective observational cohort study by chart review. The researchers propose to review the charts of women undergoing abortions between January 1, 2005 and December 31, 2006 at Kelowna General Hospital's Women's Services Clinic. The researchers will record the following data from each chart: age, parity, gestational age, date of index therapeutic abortion (TA), dates of subsequent TAs, contraception used at the time of the index conception, contraceptive method chosen post-abortion, and outcome of follow-up at two weeks, such as expulsion of IUD. The researchers will also record the recurrent pregnancy rates.
- Conditions
- Induced Abortion
- Being tested
- Device: Intrauterine device (IUD)
- Keywords
- Abortion rate, Intrauterine device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: Intrauterine device (IUD)Device
Women choosing to have an intrauterine device (IUD) inserted immediately post-abortion
| Study group | Role | What they receive |
|---|---|---|
| IUD | Repeat abortion rate in women receiving IUDs immediately post-abortion Receives: Device: Device: Intrauterine device (IUD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of repeat abortions at five years from the index abortions
Measured: 5 years
Secondary outcomes (1)
Correlation of repeat and index abortions with obstetrical, demographic and contraceptive history factors.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study startJul 2012
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: This study is a retrospective chart review study, not a clinical trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induced AbortionStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,308 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wendy Norman, University of British Columbia
- Investigators
- Wendy Norman, Dr., Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01776957
- Sponsor's protocol ID
- H12-00829
- Status last verified
- May 2018
- First submitted
- 21 Jan 2013
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Repeat Abortion: Is the Immediate Insertion of Intrauterine Devices Post-abortion a Cost-effective Option Associated With Fewer Repeat Abortions? Findings From 2005-2006 Data
- ClinicalTrials.gov ID
- NCT01776957
- Acronym / sponsor ID
- H12-00829
- Conditions
- Induced Abortion
- Keywords
- Abortion rate, Intrauterine device
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: This study is a retrospective chart review study, not a clinical trial.
- Enrolment
- 1,308 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 28 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The rate of repeat abortions will be lowest in those women who choose immediate insertion of an IUD post-abortion versus those who immediately choose oral contraceptive pills and those who indicate all other contraceptive choices including no contraception The provision by the health system of IUDs for immediate insertion will result in the lowest health system costs.
Detailed description
The investigators intend to demonstrate whether there are statistically significant differences in the rates of repeat abortions between three groups: 1. women choosing to have an intrauterine device (IUD) inserted immediately post-abortion, 2. those choosing to begin oral contraceptives immediately post-abortion, and 3. all other choices for post abortion contraception including those stating an intention to obtain contraceptives at a later time or from an alternate location or to use no contraception. This data will then be used to conduct a cost-effectiveness analysis of health system provision for cost-free IUDs post-abortion. Thus, if providing a free IUD immediately post-abortion significantly reduces the rate of repeat abortions, it may be more cost- effective for health system services to provide free IUDs at abortion clinics than to field the costs associated with a higher rate of repeat abortions.
The researchers will conduct a retrospective observational cohort study by chart review. The researchers propose to review the charts of women undergoing abortions between January 1, 2005 and December 31, 2006 at Kelowna General Hospital's Women's Services Clinic. The researchers will record the following data from each chart: age, parity, gestational age, date of index therapeutic abortion (TA), dates of subsequent TAs, contraception used at the time of the index conception, contraceptive method chosen post-abortion, and outcome of follow-up at two weeks, such as expulsion of IUD. The researchers will also record the recurrent pregnancy rates.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IUD | – | Device: Device: Intrauterine device (IUD)Repeat abortion rate in women receiving IUDs immediately post-abortion |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Female resident of Interior Health region seeking an abortion
Key inclusion criteria (1 listed)
- Female resident of Interior Health region seeking an abortion between January 1, 2005 and December 31, 2006
Key exclusion criteria (1 listed)
- Women undergoing abortions for fetal genetic abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device: Intrauterine device (IUD)Women choosing to have an intrauterine device (IUD) inserted immediately post-abortion | Device | IUD |
Primary outcome
The proportion of repeat abortions at five years from the index abortions
Time frame: 5 years
1 secondary outcome
Correlation of repeat and index abortions with obstetrical, demographic and contraceptive history factors.
Time frame: 2 months
Results and safety
The study was stopped early (reason given: This study is a retrospective chart review study, not a clinical trial.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendy Norman, Dr. principal investigator
University of British Columbia
Questions about this trial
What is this clinical trial studying?
An observational study of Induced Abortion, run by University of British Columbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: This study is a retrospective chart review study, not a clinical trial.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of repeat abortions at five years from the index abortions (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2018; AzTrials last refreshed its copy on 1 Nov 2026.